Transcript clinical research in indonesia - ina

CLINICAL RESEARCH IN
INDONESIA:
ARE WE READY?
Rianto Setiabudy
Dept. of Pharmacology
School of Medicine University of Indonesia
Jakarta, 30 April 2015
Introduction (1)
 Indonesia is an archipelago with more than
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17.000 islands
Current population: more than 230 millions With
per capita income of US $ 1.810 in 2014
There are 72 medical schools, 32 of them have
been accredited A or B
Currently, about 12 medical schools and special
hospitals are actively involved in clinical research
activity
Until 2014, there were 110.776 GPs and 19.367
specialists in Indonesia (Abidin Z – IDI, 2014)
Introduction (2)
 Today the implementation of simultaneous global
clinical trials are very important to speed up new
drug development
 Roughly, 1 day delay of marketing approval causes
loss of US $ 1.000.000, The implementation of clinical research in Indonesia
and other Asian countries is associated with some
potential benefits:
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Lower trial cost
“Less strict” regulations
Wide variety of diseases
More availability of research subjects
Many tropical diseases could not be explored in non-tropical
countries
Introduction (3)
o The question is: How can we be assured that:
 the quality of the trial meets the global
standards?
 are there clear regulations that control the
conduct of clinical trials in Indonesia?
 are the local regulations compatible with the
internationally accepted principles?
Fig. 1
Outlines
 Ethics Committee
 Local regulations
 Inspection and audit
 GCP
 Our strength and weakness
 Major health problems in Indonesia
 Issues to be settled
Why do we have to do clinical
research?
1. It helps us to solve various health problems in
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the most efficient way
It helps us to reduce cost of health care
It helps us to use the most efficacious and safe
drugs or methods to improve the our health
care
It improves the scientific image of our scientists
and our nation
It opens the door for our scientists to contribute
to mankind
Ethics Committee
 1982: the first EC was established in Indonesia
 2003: the MoH established the National
Committee on Ethics of Health Research
(KNEPK) with task to improve the capability of
ECs in Indonesia
 Today there are 55 ECs throughout Indonesia
registered in the KNEPK, 8 of them have been
recognized by the FERCAP: Litbangkes KemKes,
FK Unhas, FKUI, FK UGM, FK Unpad, FK Univ.
Udayana, FK Univ Brawijaya
Local regulations related to
the GCP and clinical trials (1)
 All pre-marketing CTs in Indonesia must meet the
GCP standard (SK Kabadan POM, 2001)
 All of these trials must obtain ethical and authority
approvals prior to their implementation.
 The procedure to obtain regulatory authority’s
approval are well described (Buku CUKB, 2001)
 In Indonesia, trials involving drugs already approved
for marketing are not required to apply for approval
if they are not intended for claiming new indications
Local regulations related to
the GCP and clinical trials (2)
 In Indonesia, in addition to evaluating the ethical
aspect, the ECs must also evaluate the scientific
aspect of clinical trial protocols
 Majority of pivotal drug-related CTs will be
inspected by the regulatory agency (routine and “for
cause”)
 All CTs must be registered to MoH
 All biological materials are not allowed to be sent to
foreign countries, except if the assays required for
the trials could not be performed by local labs
Issues requiring attention
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Contract Research Organization
Material Transfer Agreement
Accreditation of ECs
GCP trainings
Local insurance companies
Our strengths
Availability of :
 Hospitals and health centers (puskesmas)
 Capable and qualified manpower
 Regulations related to clinical research
 CROs
 Accredited clinical labs
 Strong and high quality pharmaceutical
industry
 Wide variety of diseases
Our weaknesses
 Less standardized Ethics Committees
 Lack of network in drug development
research
 Low quality of some clinical trials
 Some “less friendly” regulations
 Lack of insurance companies
 Small number of research-oriented local
pharmaceutical industry
 Most of our pharmaceutical companies lack
spirit to innovate
Our opportunities
 The global need to develop new drugs in
short period of time
 Large patient populations
 Competitiveness of research cost
 The piling up of health problems in Indonesia
Our threats
 Competing countries (especially China,
Thailand, and Vietnam)
What do we have to do?
 Quality improvement of CT implementation:
CRO, inspection, audit, GCP, protection of
human subjects
 Quality improvement of ECs: accreditation,
SOPs, independency, GCP, trainings
 Regulations: removal of regulations that may
hamper development of the role Indonesian
scientists in global clinical research, esp. for
premarketing trials
Table 1
Major communicable diseases in Indonesia
Diseases
Upper resp. tract infection
Pneumonia
Lung tuberculosis
Hepatitis
Diarrhea
Malaria
(Riskesdas, Ministry of Health of Indonesia, 2013)
Table 3
Major non-communicable diseases in
Indonesia
Diseases
Asthma
Chronic obstruct. Pulmonary
disease
Cancer
Diabetes mellitus
Hiperthyroidism
Hypertension
Coronary heart disesase
Stroke
Chronic renal failure
Kidney stone
Rheumatic diseases
(Riskesdas, Ministry of Health of Indonesia, 2013)
Conclusions
 Clinical research is the key solution for various
health problems throughout the world
 Indonesia potentially has a big opportunity to
become a prominent player in clinical research
 Some research institutions in Indonesia are
ready to carry out high quality clinical research
 More opportunity has to be given by the
sponsors to Indonesia to show its ability in
executing high quality clinical research
THANK YOU